Opioid-use DisorderPhase 4NCT04091009
Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post-Operative Opioid Use Disorder Symptoms
A Phase 4 study testing Buprenorphine/naloxone in people with Opioid-use Disorder and Opioid Use Disorder, Mild, run by Massachusetts General Hospital.
Trial summary
The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder, Opioid Use Disorder, Mild
- What is being tested?
- Buprenorphine/naloxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) health class I-III
- Currently taking buprenorphine or buprenorphine/naloxone daily at a dose of at least 16mg per day for at least the prior 30 days for treatment of Opioid Use Disorder by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
- Scheduled for surgery at Massachusetts General Hospital where greater than 3/10 pain is expected on post-operative day 1
Who cannot join
- Participants unable to consent to the study
- Renal insufficency with a glomerular filtration rate <30ml/min (participants would be unable to use ketorolac which is a part of the multimodal anesthetic plan)
- Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score > 25 (participants would be unable to use Tylenol which is part of the multimodal anesthetic plan)
About this study
Official title: Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain and Opioid Use Disorder Symptoms
The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. The management of pain after surgery in adults taking buprenorphine can be challenging, as buprenorphine may interfere with the effectiveness of other medications used to treat pain.
The investigators want to compare how well pain is managed after surgery ("post-op") in two groups:
Read more
The "Continue Group": those who continue taking their standard dose of buprenorphine before, during and after surgery.
The "Reduce Group": those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, participants will be put back on their full dose of buprenorphine.
The investigators also want to find out if there is a difference in pain, opioid cravings, and relapse rates in the month following surgery.
- Conditions
- Opioid-use Disorder, Opioid Use Disorder, Mild
- Being tested
- Buprenorphine/naloxone
- Medical subject headings
- Opioid-Related Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/naloxoneDrug
Participants will be prescribed 8mg buprenorphine daily from the day of surgery until transitioned back to their regular dose of buprenorphine when postoperative surgical pain has subsided
| Study group | Role | What they receive |
|---|---|---|
| Continue Group | Active comparator | Those who continue taking their standard dose of buprenorphine before, during and after surgery. Receives: Drug: Buprenorphine/naloxone |
| Reduce Group | Active comparator | Those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, you will be put back on your full dose of buprenorphine. Receives: Drug: Buprenorphine/naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores at 24 hours post-operative procedure
Average pain scores at 24 hours post-op
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhang, MD, Massachusetts General Hospital
- Investigators
- Zhang Yi, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091009
- Sponsor's protocol ID
- 2019P001092
- Status last verified
- Dec 2025
- First submitted
- 13 Sep 2019
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain and Opioid Use Disorder Symptoms
- ClinicalTrials.gov ID
- NCT04091009
- Acronym / sponsor ID
- 2019P001092
- Conditions
- Opioid-use Disorder, Opioid Use Disorder, Mild
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare two ways of managing pain in people who are taking buprenorphine and are scheduled to undergo surgery. Buprenorphine (subutex) and buprenorphine/naloxone (suboxone) are effective long-term treatments for substance use disorders. The management of pain after surgery in adults taking buprenorphine can be challenging, as buprenorphine may interfere with the effectiveness of other medications used to treat pain.
The investigators want to compare how well pain is managed after surgery ("post-op") in two groups:
The "Continue Group": those who continue taking their standard dose of buprenorphine before, during and after surgery.
The "Reduce Group": those who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, participants will be put back on their full dose of buprenorphine.
The investigators also want to find out if there is a difference in pain, opioid cravings, and relapse rates in the month following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue Group | Active comparator | Drug: Buprenorphine/naloxoneThose who continue taking their standard dose of buprenorphine before, during and after surgery. |
| Reduce Group | Active comparator | Drug: Buprenorphine/naloxoneThose who are placed on a lower dose of buprenorphine starting one day before surgery and during the time period after surgery until the pain from the surgery has decreased. Once the pain from the surgery has decreased, you will be put back on your full dose of buprenorphine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) health class I-III
- Currently taking buprenorphine or buprenorphine/naloxone daily at a dose of at least 16mg per day for at least the prior 30 days for treatment of Opioid Use Disorder by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria
- Scheduled for surgery at Massachusetts General Hospital where greater than 3/10 pain is expected on post-operative day 1
Key exclusion criteria (3 listed)
- Participants unable to consent to the study
- Renal insufficency with a glomerular filtration rate <30ml/min (participants would be unable to use ketorolac which is a part of the multimodal anesthetic plan)
- Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score > 25 (participants would be unable to use Tylenol which is part of the multimodal anesthetic plan)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine/naloxoneParticipants will be prescribed 8mg buprenorphine daily from the day of surgery until transitioned back to their regular dose of buprenorphine when postoperative surgical pain has subsided | Drug | Continue Group, Reduce Group |
Primary outcome
Pain scores at 24 hours post-operative procedure
Time frame: 24 hours
Average pain scores at 24 hours post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Yi, MD PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine/naloxone in people with Opioid-use Disorder and Opioid Use Disorder, Mild, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores at 24 hours post-operative procedure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.